BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790082 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14101
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE NUMBER OF TURN TO EXTEND/RETRACT THE HELIX EXCEEDS SPECIFICATION, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE HELIX IS BENT CAUSING IT TO STICK ON THE STEROID RING. THE TURNS ARE OUT OF SPECIFICATION DUE TO THE BENT HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE LEAD, THE LEAD HAD TO BE REPOSITIONED TWICE AND THE PHYSICIAN THOUGHT IT TOOK TOO MANY TURNS TO MOVE THE HELIX. THE STYLET BECAME STUCK IN THE LEAD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other